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A Novel Imaging Based Quantitative Model-aided Detection of Portal Hypertension in Patients With Cirrhosis (CHESS2104)

A Novel Imaging Based Quantitative Model-aided Detection of Portal Hypertension in Patients With Cirrhosis (CHESS2104): A Prospective, Multicenter Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05068492
Enrollment
2000
Registered
2021-10-05
Start date
2023-12-10
Completion date
2025-12-01
Last updated
2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal Hypertension

Keywords

Cirrhosis, Portal hypertension, Artificial intelligence, CT, MRI, Ultrasound

Brief summary

How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of hepatic venous pressure gradient (HVPG) is an important general problem in the management of portal hypertension in cirrhosis. We plan to investigate the ability of AI analysis of Ultrasound, computed tomography (CT) or magnetic resonance (MR) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis.

Detailed description

China suffers the heaviest burden of liver disease in the world. The number of chronic liver disease is more than 400 million. Either viral-related hepatitis, alcoholic hepatitis, or metabolic-related fatty hepatitis, etc. may progress to cirrhosis, which greatly threatens public health. Portal hypertension is a critical risk factor that correlates with clinical prognosis of patients with cirrhosis. According to the Consensus on clinical application of hepatic venous pressure gradient in China (2018), hepatic venous pressure gradient (HVPG) greater than 10,12,16,20 mmHg correspondingly predicts different outcomes of patients with cirrhosis portal hypertension. It is of great significance to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis. As a universal gold standard for diagnosing and monitoring portal hypertension, HVPG remains limitation for clinical application due to its invasiveness. How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of HVPG is an important general problem in the management of portal hypertension in cirrhosis. The development of radiomics technique provides an approach to solve abovementioned clinical issues. Based on artificial intelligence algorithms, radiomics harnesses mineable, high-resolution, and quantitative features from encrypted medical images, along with clinical or genetic data to produce evidence-based decision support system, to achieve the clinical targets including diagnosis, treatment effect evaluation, and prognosis prediction. In this project, aiming at development of a risk stratification system for hypertension management in cirrhosis, we will construct a standard-of-care database and utilize radiomics tool to construct the decision making system. We will take responsibility for achievement of organ and vessel segmentation, radiomic feature selection, and signature construction for prediction of hypertension classification, and accomplish the development of prototype system which would integrate four modules including database management, HVPG risk stratification application module, predicted outcome presentation module, and prognostic information curation module. This project will focus on two aspects which are correspondingly machine learning algorithms optimization and prototype system development, so as to promote the precision medicine in liver disease.

Interventions

DIAGNOSTIC_TESTCT

enhanced CT with standard procedure

DIAGNOSTIC_TESTMRI

enhanced MRI with standard procedure

DIAGNOSTIC_TESTHVPG

HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures

DIAGNOSTIC_TESTUltrasound

Digestive ultrasound with standard procedure

Sponsors

Portal Hypertension Alliance in China
CollaboratorUNKNOWN
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. age \> 18 years old; 2. confirmed cirrhosis (laboratory, imaging and clinical symptoms); 3. with ultrasound/CT/MRI within 1 month prior to HVPG measurement; 4. written informed consent.

Exclusion criteria

1. any previous liver or spleen surgery; 2. liver cancer; chronic acute liver failure; 3. acute portal hypertension; 4. unreliable HVPG or ultrasound/CT/MRI results due to technical reasons. 5. with liver interventional therapy between HVPG and ultrasound/CT/MRI

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic value24 monthsAccuracy of the novel model for virtual HVPG

Contacts

Primary ContactYifei Huang
huangyf1995@foxmail.com15800004518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026